Device for in situ positioning of cardiac valve prosthesis

• US 8,470,024 B2
• Filed: 12/19/2006
• Issued: 06/25/2013
• Est. Priority Date: 12/19/2006
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Ghione, Laura, Righini, Giovanni, Manasse, Eric, Rolando, Giovanni, Gaschino, Paolo, Shin, Dong Ik
• Primary Examiner(s): Tyson, Melanie
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US11/612,968
• Publication Number:
  US 20080147180A1
• Time in Patent Office: 2,380 Days
• Field of Search: 623/2.11, 623 111- 112, 606/127, 606/198
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath

Abstract

An instrument for positioning a cardiac valve prosthesis in a vessel includes a wire element to slidingly guide the valve prosthesis towards an implantation site and an expandable element coupled to the wire element. The expandable element is expandable in the vessel to position the wire element in association with the implantation site. A method for positioning a cardiac valve prosthesis includes securing a delivery instrument at an appropriate location at the implantation site and delivering the valve prosthesis to the implantation site using the delivery instrument.

Claims

1. An improved device for delivering an expandable cardiac valve prosthesis to a desired position in a vessel, the device comprising:

a deployment instrument including a deployment element adapted to constrain the expandable cardiac valve prosthesis in a radially contracted position for delivery to and deployment at the desired position in the vessel;

a wire or wire-like element adapted to facilitate advancement of the deployment instrument, the wire or wire-like element including an abutment element that is connected to the wire element and configured to limit advancement of the deployment instrument at a desired location along the wire or wire-like element; and

an expandable element coupled to the wire element, the expandable element having a cage-shaped expanded configuration that permits blood flow at all times through the vessel, the expandable element operable to axially secure the wire element along a central longitudinal axis of the vessel and with respect to the desired position of the expandable cardiac valve prosthesis in the vessel;

wherein the abutment element includes a collar sized and dimensioned to prohibit axial movement of the deployment instrument and permit the flow of blood at all times past the abutment element, the abutment element positioned proximal to the expandable element such that the deployment instrument is maintained at a location along the wire element proximal to the expandable element, and the abutment element positioned at all times distal to the deployment instrument and configured to limit advancement of the deployment instrument such that during use the abutment element operates to axially align the deployment instrument with the desired position in the vessel.

2. The improved device of claim 1 in which said abutment element can be variably positioned along the length of said wire or wire-like element.

3. The improved device of claim 1 further comprising a filtering element capable of removing debris emanating from a diseased native valve while permitting the flow of blood therethrough.

4. The improved device of claim 1 further comprising one or more markers visually perceptible using an imaging technique.

5. The improved device of claim 1 further comprising a sensor to indicate said prosthesis has reached a desired location on said guide wire.

6. An improved device for delivering an expandable cardiac valve prosthesis to a desired position in a vessel, the device comprising:

a wire element adapted to facilitate advancement of the valve prosthesis, the wire element including an abutment element that is connected to the wire element and configured to limit advancement of the prosthesis at a desired location along the wire element; and

an expandable element coupled to the wire element, the expandable element having a cage-shaped expanded configuration that allows blood flow at all times through the vessel, the expandable element operable to axially secure the wire element along a central longitudinal axis of the vessel and with respect to the desired position of the expandable cardiac valve prosthesis in the vessel;

wherein the abutment element includes a collar sized and dimensioned to prohibit axial movement of the prosthesis and permit the flow of blood at all times past the abutment element, the abutment element positioned proximal to the expandable element such that the valve prosthesis is maintained at a location along the wire element proximal to the expandable element, and the abutment element positioned at all times distal to the expandable cardiac valve prosthesis and configured to limit advancement of the expandable cardiac valve prosthesis such that during use the abutment element operates to axially align the expandable cardiac valve prosthesis with the desired position in the vessel; and

a sensor coupled to the device.

7. The improved device of claim 6 in which said sensor further comprises a sensor indicating that said cardiac valve prosthesis is at a desired location on said device.

8. The improved device of claim 6 comprising a plurality of sensors.

9. The improved device of claim 8 in which said plurality of sensors indicate varying positions of said prosthesis along a path of travel.

10. The improved device of claim 8 in which at least one of said sensors measures a physiological state.

11. The improved device of claim 8 in which said physiological state is blood pressure.

12. The improved device of claim 6 in which at least one of said sensors measures the radial orientation of said prosthesis.

13. The improved device of claim 6 in which at least one of said sensors is capable of measuring the width of a vessel.

14. The improved device of claim 13 in which said sensor is capable of measuring pressure differentials.

15. An improved device for delivering an expandable cardiac valve prosthesis to a desired position in a vessel, the improvement comprising:

a wire element adapted to facilitate advancement of the valve prosthesis, the wire element including an abutment element that is connected to the wire element and configured to limit advancement of the prosthesis at a desired location along the wire element;

wherein the abutment element includes a collar operable to prohibit axial movement of the prosthesis, while simultaneously permitting the flow of blood at all times past the abutment element;

an expandable element coupled to the wire element, the expandable element having a cage-shaped expanded configuration that allows blood flow at all times through the vessel, the expandable element operable to axially secure the wire element along a central longitudinal axis of the vessel and with respect to the desired position of the expandable cardiac valve prosthesis in the vessel; and

a marker coupled to the wire element;

wherein the abutment element is positioned proximal to the expandable element such that the valve prosthesis is maintained at a location along the wire element proximal to the expandable element, and the abutment element positioned at all times distal to the expandable cardiac valve prosthesis and configured to limit advancement of the expandable cardiac valve prosthesis such that during use the abutment element operates to axially align the expandable cardiac valve prosthesis with the desired position in the vessel.

16. The improved device of claim 15 further comprising a plurality of markers.

17. The improved device of claim 15 in which said marker is visible using an external imaging technique.

18. The improved device of claim 15 in which said marker is sized and located to provide a visual image, externally of a patient, of the location of a cardiac valve prosthesis located within said patient.

19. The device of claim 15 further comprising an expandable cardiac valve prosthesis.